Post-Market Clinical Follow-up
Bringing a medical device to the European market implies you must go through various stages of design and development to
ensure compliance with relevant regulations. For devices in the pre-market phase, the EU Medical Device Regulation (MDR 2017/745) places significant emphasis on the connection between Risk Management and Clinical Evaluation. Additionally, in the post-market phase, Post-Market Surveillance (PMS) becomes an integral component.
Want to know more about PMCF? Our experts are happy to help. Don’t hesitate to contact us for more information.
Pre-market vs Post-market
Pre-Market
In the pre-market phase, collecting ample evidence to validate the safety and performance of your device is key. That way you ensure the intended use of your device and the claims you prefer to make are supported by robust clinical data while mitigating associated risks as far as possible.Â
Post-Market
In the post-market phase, additional PMS activities are crucial. PMS involves setting up mechanisms for continuous collection of safety and performance data from the real-world use of your device. PMS activities can be either reactive (e.g. vigilance, management of complaints), proactive (PMCF activities) or a combination of both. PMS data help maintaining the continuous safety and performance profile of your device, ensuring that the benefits continue to outweigh the risks.
PMCF
PMCF, as part of the PMS process, involves a proactive collection and evaluation of data from the clinical use of your CE marked device. The process provides valuable insights into the long-term effectiveness of the device, and it is a way to potentially detect emerging risks.
PMCF can be done in various ways. The most common PMCF activities are listed in the table below, each of them providing a different level of evidence. It is important for every Medical Device Manufacturer to identify the activities that are most relevant (general or specific methods), taking into consideration the risk class of the device and the purpose of the post-market data collection.
Type of method | Most common PMCF activities |
|---|---|
General method | Case reports |
General method | User feedback |
General method | Literature/published research on the device safety and performance |
General method | Safety database searches (e.g. FDA Maude) |
Specific method | Evaluation of registers |
Specific method | PMCF Survey |
Specific method | PMCF study (interventional or observational) |
Specific method | Investigator Initiated studies |
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The results of PMCF activities, as part of the PMS process, are taken up in the clinical evaluation and as such the process contributes to the ongoing risk management of the device.
Why QbD Group?
The QbD Clinical team is well-equipped to support you in designing and executing various PMCF activities, tailored to their specific regulatory requirements and your device characteristics.
Whether it’s scouring through literature, sifting through customer feedback, or setting up reliable data collection methods. We maintain a strong commitment to attention to detail and strict adherence to regulatory standards.
In addition to assisting with PMCF activities, QbD Clinical can also provide robust support in documenting your PMS and Clinical Evaluation processes, ensuring thorough preparation for scrutiny by your Notified Body
Contact us
Interested in our PMCF service? Don’t hesitate to contact us and provide the details of your request including scope and expected timelines. We will contact you shortly to discuss these details and further steps.
